New Cholesterol Treatment Options Needed

Study Overview

Recent research has highlighted the necessity for innovative cholesterol treatments. A study focused on a drug named bempedoic acid and its potential effectiveness when used alongside existing cholesterol-lowering medications. LDL cholesterol, often labeled as “bad cholesterol,” can accumulate in blood vessels, significantly contributing to cardiovascular diseases, which can result in heart attacks or strokes.

The Role of Statins

Current therapies, including statins, are utilized to reduce LDL cholesterol levels. However, they do not always meet desired target levels and can induce side effects, such as muscle pain. This limitation has prompted ongoing research for alternative cholesterol treatments.

Bempedoic Acid: A New Approach

Targeting the Liver

Bempedoic acid is a newly identified drug that may complement statin therapy by targeting the liver, where the majority of LDL cholesterol is produced. This localized action may minimize the risk of side effects commonly associated with statins.

Study Design and Participant Details

The recent study, published in The New England Journal of Medicine, included over 2,000 participants, most of whom had cardiovascular disease and maintained an average LDL cholesterol level exceeding 100 mg/dl. The average age of participants was 66, with around 75% being male. All participants were on the maximum tolerated dosage of cholesterol-lowering medications, primarily statins, throughout the study.

At the outset, participants were randomly assigned to two groups: one receiving bempedoic acid and the other a placebo. This was a double-blind study, ensuring that neither the patients nor the healthcare providers knew who received which treatment.

Side Effects and Safety Profile

The study found that bempedoic acid did not lead to more side effects than the placebo. However, 22% of patients on bempedoic acid discontinued the drug for various reasons, compared to only 5% of those on the placebo. While some undesirable effects were reported, muscle pain— a notable side effect of statins—was infrequent among bempedoic acid users. Fifteen patient deaths occurred during the study, but researchers concluded that these were largely unrelated to the cholesterol treatment.

Efficacy of Bempedoic Acid

Reduction in LDL Cholesterol Levels

Bempedoic acid effectively lowered LDL cholesterol levels in most participants. Initial results showed a decrease within a month, with levels dropping by 18% after three months. Specifically, LDL cholesterol levels fell from over 100 mg/dl to between 85 and 90 mg/dl, and remained reduced throughout the year-long study.

Bempedoic acid demonstrated consistent efficacy across various demographics, including men and women, different age groups, and individuals with varying initial LDL cholesterol levels.

Conclusion: A Promising New Treatment

The comprehensive study presents strong evidence supporting bempedoic acid as an effective option for lowering LDL cholesterol levels. Patients can potentially use this drug safely alongside their current cholesterol-lowering therapies.

Despite the challenge posed by a notable percentage of patients discontinuing the drug, the reasons remain unclear since bempedoic acid users did not report higher side effects than those taking the placebo. If approved, it will be essential for healthcare providers to monitor patients on bempedoic acid closely to manage any emerging issues.

References

Ray, K. K., Bays, H. E., Catapano, A. L., Lalwani, N. D., Bloedon, L. T., Sterling, L. R., Robinson, P. L. & Ballantyne, C. M. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. New England Journal of Medicine 380, 1022-1032 (2019). https://www.nejm.org/doi/10.1056/NEJMoa1803917
O’Hare, R. New cholesterol-lowering drug could help patients unable to take statins. March 13 2019. https://www.imperial.ac.uk/news/190532/new-cholesterollowering-drug-could-help-patients/